Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-15 @ 11:15 AM
Study NCT ID:
NCT01535560
Status:
COMPLETED
Last Update Posted:
2013-12-10
First Post:
2012-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Sally Schieb, Sr. Clinical Project Lead', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study (6 months).', 'description': 'This reporting group includes all participants who received study drug. Adverse events were obtained as solicited comments from the study patients and as observations by the study investigator.', 'eventGroups': [{'id': 'EG000', 'title': 'AL-60371', 'description': 'AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days', 'otherNumAtRisk': 274, 'otherNumAffected': 0, 'seriousNumAtRisk': 274, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle', 'description': 'AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days', 'otherNumAtRisk': 274, 'otherNumAffected': 0, 'seriousNumAtRisk': 274, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AL-60371', 'description': 'AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '68.7', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 11', 'description': 'An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. Proportion of patients is reported as percentage of participants.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AL-60371', 'description': 'AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 11', 'description': 'Microbiological success was considered attained if all pre-therapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. Proportion of patients is reported as a percentage of participants.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline.'}, {'type': 'SECONDARY', 'title': 'Median Time (in Days) to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guadian Via the Telephone Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AL-60371', 'description': 'AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time to event (Day 1 to Day 11)', 'description': 'Cessation of ear pain was defined as occurring the first time point that ear pain was absent (morning or evening) and did not reoccur in any subsequent diary entries.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline, minus missing responses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AL-60371', 'description': 'AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days'}, {'id': 'FG001', 'title': 'Vehicle', 'description': 'AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '274'}, {'groupId': 'FG001', 'numSubjects': '275'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '237'}, {'groupId': 'FG001', 'numSubjects': '179'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '96'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Subj Decision Unrel to an Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Treatment Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Randomized in Error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from 53 investigational centers located in the United States, Puerto Rico, and Canada.', 'preAssignmentDetails': 'Of the 589 participants enrolled, 40 were exited from the study as screen failures prior to randomization. This reporting group includes all randomized participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '548', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AL-60371', 'description': 'AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days'}, {'id': 'BG001', 'title': 'Vehicle', 'description': 'AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Infants and Toddlers (28 days to 23 months)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Children (2 to 11 years)', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}]}, {'title': 'Adolescents (12 to 17 years)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}, {'title': 'Adults (18 to 64 years)', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}, {'title': 'Elderly (≥ 65 years)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '318', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This reporting group includes all randomized participants who received the study drug (ie, 548). Note: 1 participant in the Vehicle arm was randomized in error and did not receive the study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 589}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-18', 'studyFirstSubmitDate': '2012-02-15', 'resultsFirstSubmitDate': '2013-10-18', 'studyFirstSubmitQcDate': '2012-02-15', 'lastUpdatePostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-18', 'studyFirstPostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit', 'timeFrame': 'Day 11', 'description': 'An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. Proportion of patients is reported as percentage of participants.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit', 'timeFrame': 'Day 11', 'description': 'Microbiological success was considered attained if all pre-therapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. Proportion of patients is reported as a percentage of participants.'}, {'measure': 'Median Time (in Days) to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guadian Via the Telephone Diary', 'timeFrame': 'Time to event (Day 1 to Day 11)', 'description': 'Cessation of ear pain was defined as occurring the first time point that ear pain was absent (morning or evening) and did not reoccur in any subsequent diary entries.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute otitis externa'], 'conditions': ['Acute Otitis Externa']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to demonstrate superiority of AL-60371 relative to Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).', 'detailedDescription': 'Participants or legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear medication use, and impact of ear pain on sleep and other daily activities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 6 months of age.\n* Clinical diagnosis of acute otitis externa (AOE) based on clinical observation and of presumed bacterial origin in at least one ear.\n* Combined numerical score of ≥4 in at least one affected ear at the Day 1 exam for tenderness, erythema, and edema.\n* Agree to refrain from water immersion of the ears during the conduct of the entire study.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Duration of signs or symptoms of AOE greater than 28 days in the affected ear(s) as reported by patient or parent/guardian.\n* Presence of a tympanostomy tube or perforated tympanic membrane in the affected ear(s).\n* Clinically diagnosed otic disease other than AOE (eg, malignant otitis externa) in the affected ear(s).\n* Known or suspected ear infection of yeast, fungal or mycobacterial origin in the affected ear(s).\n* Prior otologic surgery within 6 months of study entry in the affected ear(s).\n* Known or suspected allergy or hypersensitivity to quinolones or other ingredients present in the medications to be used in the study.\n* Patients who use ear plugs, head phones or ear buds and are unwilling to discontinue their use during the study period.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01535560', 'briefTitle': 'Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa', 'orgStudyIdInfo': {'id': 'C-10-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AL-60371', 'description': 'AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days', 'interventionNames': ['Drug: AL-60371, 0.3% otic suspension']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days', 'interventionNames': ['Drug: AL-60371 Vehicle']}], 'interventions': [{'name': 'AL-60371, 0.3% otic suspension', 'type': 'DRUG', 'description': 'Investigational otic suspension intended for the treatment of acute otitis externa', 'armGroupLabels': ['AL-60371']}, {'name': 'AL-60371 Vehicle', 'type': 'DRUG', 'description': 'Inactive ingredients used as placebo', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sally Schieb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}